Magnetic Resonance Imaging to Evaluate Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2004 |
| End Date: | September 2007 |
Comprehensive Prostate MRI for the Evaluation of Prostate Cancer at 3.0T: A Pilot Study
This study will determine whether scanning the prostate using special magnetic resonance
imaging (MRI) techniques can detect prostate cancers with greater accuracy than other
methods. MRI uses a strong magnet and radio waves to produce images of body tissues. Unlike
many cancers, prostate cancer is difficult to see on most imaging studies like x-rays,
computed tomography (CT) scans, and conventional MRI scans. This study will use a magnet
twice as strong as the magnets commonly used in MRI tests.
Patients 18 years of age and older with prostate cancer confirmed by prostate biopsy may be
eligible for this study. Candidates are screened with a medical history, physical
examination, and review of pathology reports.
Participants undergo MRI of the prostate and possibly a biopsy of the prostate gland, as
follows:
Prostate MRI
Before coming to the NIH Clinical Center for the biopsy, patients take a Fleets enema to
empty the rectum of fecal matter. For the MRI, an endorectal coil (a tube containing a
specially designed antenna) is placed in the rectum, which is just behind the prostate. The
coil increases the amount of signal received by the MRI unit. Additional coils may be
wrapped around the pelvis to further improve the quality of the scan. The patient lies on a
stretcher that moves into the scanner. A catheter (plastic tube) is placed in an arm vein
for injection of a contrast agent called gadolinium, which brightens the images. Patients
may also be asked to breathe an oxygen-rich gas through a mask during the scan to test the
use of oxygen as a contrast agent in MRI. Patients may be asked to repeat the MRI to test
the reproducibility of the procedure. The repeat test is optional.
Prostate Biopsy
Depending on the MRI findings, patients may be asked to undergo a prostate biopsy to obtain
a sample of tumor tissue. The tissue is obtained with a needle placed through the rectum.
Medicines may be used to reduce pain during the biopsy and to reduce the chance of
infection.
imaging (MRI) techniques can detect prostate cancers with greater accuracy than other
methods. MRI uses a strong magnet and radio waves to produce images of body tissues. Unlike
many cancers, prostate cancer is difficult to see on most imaging studies like x-rays,
computed tomography (CT) scans, and conventional MRI scans. This study will use a magnet
twice as strong as the magnets commonly used in MRI tests.
Patients 18 years of age and older with prostate cancer confirmed by prostate biopsy may be
eligible for this study. Candidates are screened with a medical history, physical
examination, and review of pathology reports.
Participants undergo MRI of the prostate and possibly a biopsy of the prostate gland, as
follows:
Prostate MRI
Before coming to the NIH Clinical Center for the biopsy, patients take a Fleets enema to
empty the rectum of fecal matter. For the MRI, an endorectal coil (a tube containing a
specially designed antenna) is placed in the rectum, which is just behind the prostate. The
coil increases the amount of signal received by the MRI unit. Additional coils may be
wrapped around the pelvis to further improve the quality of the scan. The patient lies on a
stretcher that moves into the scanner. A catheter (plastic tube) is placed in an arm vein
for injection of a contrast agent called gadolinium, which brightens the images. Patients
may also be asked to breathe an oxygen-rich gas through a mask during the scan to test the
use of oxygen as a contrast agent in MRI. Patients may be asked to repeat the MRI to test
the reproducibility of the procedure. The repeat test is optional.
Prostate Biopsy
Depending on the MRI findings, patients may be asked to undergo a prostate biopsy to obtain
a sample of tumor tissue. The tissue is obtained with a needle placed through the rectum.
Medicines may be used to reduce pain during the biopsy and to reduce the chance of
infection.
Progress in effective local therapy of prostate cancer has been stymied by the lack of an
imaging technique capable of reliably identifying the location of cancer within the
prostate. Magnetic Resonance Imaging is a promising candidate for imaging the prostate
because of its high soft tissue contrast, multiplanar capabilities, and the potential for
providing unique biologic information not available with other modalities. In addition to
conventional T2-weighted imaging MRI techniques that provide unique biologic information
include MR spectroscopy, diffusion weighted MRI, dynamic enhanced MRI and hypoxia imaging.
All have shown promise in imaging tumors at a magnetic field strength of 1.5 Tesla but all
have been limited by sensitivity. Since MR signal is proportional to magnetic field
strength, 3.0 Tesla clinical systems potentially could improve overall diagnostic accuracy.
A comprehensive imaging package which incorporates all these techniques to study prostate
cancer on a state-of-the-art 3.0 Tesla magnet has not yet been developed.
In this pilot study we seek to develop and evaluate a comprehensive prostate MR exam at 3.0
Tesla. Patients with biopsy proven prostate cancer will undergo an MRI with endorectal and
surface phased array coils which will include conventional sequences, MR spectroscopy,
Diffusion weighted MRI, Dynamic enhanced MR and Hypoxia imaging. In the development phase of
this trial (30 patients), the robustness of the techniques and test-retest reproducibility
will be evaluated. In the second phase, the comprehensive prostate MRI exam will be
validated against the results of prostate biopsy (50 patients). The expected accrual period
is two years. We hope that this method will offer prostate cancer patients a more accurate
method of localizing their prostate cancer than is now possible which should improve
outcomes and minimize complications of treatment.
imaging technique capable of reliably identifying the location of cancer within the
prostate. Magnetic Resonance Imaging is a promising candidate for imaging the prostate
because of its high soft tissue contrast, multiplanar capabilities, and the potential for
providing unique biologic information not available with other modalities. In addition to
conventional T2-weighted imaging MRI techniques that provide unique biologic information
include MR spectroscopy, diffusion weighted MRI, dynamic enhanced MRI and hypoxia imaging.
All have shown promise in imaging tumors at a magnetic field strength of 1.5 Tesla but all
have been limited by sensitivity. Since MR signal is proportional to magnetic field
strength, 3.0 Tesla clinical systems potentially could improve overall diagnostic accuracy.
A comprehensive imaging package which incorporates all these techniques to study prostate
cancer on a state-of-the-art 3.0 Tesla magnet has not yet been developed.
In this pilot study we seek to develop and evaluate a comprehensive prostate MR exam at 3.0
Tesla. Patients with biopsy proven prostate cancer will undergo an MRI with endorectal and
surface phased array coils which will include conventional sequences, MR spectroscopy,
Diffusion weighted MRI, Dynamic enhanced MR and Hypoxia imaging. In the development phase of
this trial (30 patients), the robustness of the techniques and test-retest reproducibility
will be evaluated. In the second phase, the comprehensive prostate MRI exam will be
validated against the results of prostate biopsy (50 patients). The expected accrual period
is two years. We hope that this method will offer prostate cancer patients a more accurate
method of localizing their prostate cancer than is now possible which should improve
outcomes and minimize complications of treatment.
- INCLUSION CRITERIA:
Recent transrectal biopsy of the prostate gland in which at least sextant biopsies were
obtained. Knowledge of the location of each specimen is required for inclusion.
Age greater than or equal to18 years.
ECOG performance status of 0 or 1.
Informed consent: All patients must sign a document of informed consent indicating their
understanding of the investigational nature and risks of the study before any protocol
related studies are performed.
EXCLUSION CRITERIA:
Patients with contraindication to endorectal coil placement.
- Bleeding disorder documented by history.
- Severe immunocompromise documented by history.
- PT/PTT greater than 1.5 times the upper limit of normal.
- Platelets less than 50K.
- Artificial heart valve.
- Severe hemorrhoids.
- Surgically absent rectum.
Patients with contraindications to MRI.
- Patients weighing greater than 136 kg (weight limit for scanner table).
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or other
implanted electronic devices not compatible with MRI.
Patients with contraindications to prostate biopsy.
- See above contraindications for endorectal coil placement.
- Previous severe adverse event with prostatic biopsies.
Patients with distant metastatic disease.
Patients with a prior history of pelvic or prostate radiotherapy.
Patient with a prior history of androgen ablative hormonal therapy (orchiectomy, LHRH
analogues, anti-androgens).
Cognitively impaired patients who cannot give informed consent.
Other medical conditions deemed by the PI or associates to make the patient ineligible for
protocol procedures.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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